MAUDE Adverse Event Report: US SURGICAL PUERTO RICO PURSTRING; CLAMP, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number	020730
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Tissue Breakdown (2681)
Date of Event	02/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during a laparotomy colon resection procedure, the suture on one side was disconnected before firing the device.So when the tissue was cut off after the needle was operated, the surgeon opened the jaws and discovered that the suture was not caught at the tissue stump, it was not secured.To resolve the issue, a new device was used to re- fire, and the tissue was redissected.After the operation, the device was dropped, and the stapler part was damaged.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted both of the cartridges were disengaged from the jaws along with the suture.It was reported that the suture disengaged.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue may occur when contact is made when excessive force is applied during clinical application.The evaluation detected an unreported condition: the cartridge disengaged.Visual inspection noted the cartridges were disengaged from the jaws of the device.The most likely cause could not be established from the information available.This issue may occur when contact is made when excessive force is applied during clinical application.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: when closing the instrument jaws, the ring handles must be squeezed until they lock together.Failure to lock the handles may result in improperly formed staples.Improperly formed staples may compromise the integrity of the purse-string closure.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: PURSTRING
• Common Device Name: CLAMP, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer (Section G): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 18969490
• Report Number: 2647580-2024-01356
• Device Sequence Number: 6666202
• Product Code: GDJ
• UDI-Device Identifier: 10884521051478
• UDI-Public: 10884521051478
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K901107
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 020730
• Device Catalogue Number: 020730
• Device Lot Number: P2A0295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/29/2024
• Supplement Date Received by Manufacturer: 05/09/2024
• Initial Report FDA Received Date: 03/25/2024
• Supplement Report FDA Received Date: 05/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown